[Federal Register Volume 85, Number 28 (Tuesday, February 11, 2020)]
[Notices]
[Pages 7776-7778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02671]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection;
Comment Request
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995 concerning the opportunity for public comment on proposed
collections of information, the Substance Abuse and Mental Health
Services Administration (SAMHSA) will publish periodic summaries of
proposed projects. To request more information on the proposed projects
or to obtain a copy of the information collection plans, call the
SAMHSA Reports Clearance Officer at (240) 276-0361.
Comments are invited on: (a) Whether the proposed collections of
information are necessary for the proper performance of the functions
of the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use
[[Page 7777]]
of automated collection techniques or other forms of information
technology.
Proposed Project: Mandatory Guidelines for Federal Workplace Drug
Testing Programs (OMB No. 0930-0158)--Revision
SAMHSA will request OMB approval for a revision of the Federal Drug
Testing Custody and Control Form (CCF) for federal agency and federally
regulated drug testing programs which must comply with the HHS
Mandatory Guidelines for Federal Workplace Drug Testing Programs using
Urine (UrMG) dated January 23, 2017 (82 FR 7920) and using Oral Fluid
(OFMG) dated October 25, 2019, and OMB approval for information
provided by test facilities (laboratories and Instrumented Initial Test
Facilities, IITFs) for the National Laboratory Certification Program
(NLCP).
The CCF is used by all federal agencies and employers regulated by
the Department of Transportation (DOT) and the Nuclear Regulatory
Commission (NRC) to document the collection and chain of custody of
urine specimens at the collection site, for HHS-certified test
facilities to report results, and for Medical Review Officers (MROs) to
document and report a verified result. SAMHSA allows the use of the CCF
as a paper or electronic form.
The current OMB-approved CCF has an August 31, 2020 expiration
date. SAMHSA has resubmitted the CCF with major content revisions to
the form for OMB approval. These revisions are:
Copies 1-5
Revised Step 1
1. Added ``Collector Contact Info:'' and ``Other'' line (e.g., email)
Revised Step 2
1. Put Urine and Oral Fluid checkboxes above Step 2 for collector to
annotate
2. Expanded to 4 lines for collector entries:
--General entry for Split, Single, or None Provided (same as
current)
--Entries specific to urine collection (moved ``Collector reads
urine temperature within 4 minutes'' here; other entries same as
current)
--Entries specific to oral fluid collection: added ``Split Type''
with checkboxes for Serial, Concurrent, and Subdivided; ``Each Device
Within Expiration Date?'' with checkboxes Yes or No; and Volume
Indicator(s) Observed checkbox)
--Remarks (same as current)
Revised Step 3
1. Edited instruction to state ``collector affixes seal(s) to
bottle(s)/tube(s)''
Revised Step 4 (Collector Section)
1. Edited ``Specimen Bottle(s) Released To'' box to state ``Specimen
Bottle(s)/Tubes(s) Released To''
Copy 1 (Test Facility Copy)
Revised Step 4 (Accessioner Section)
1. Edited ``Specimen Bottle(s) Released To'' box to state ``Specimen
Bottle(s)/Tubes(s) Released To''
2. Added ``Primary/Single Specimen Device Expiration Date'' and ``Split
Specimen Device Expiration Date'' fields for accessioner to annotate
expiration dates of oral fluid collection devices
Revised Step 5a (Certification and Reporting Section)
1. Removed analyte names and checkboxes
2. Repositioned results and checkboxes: Moved REJECTED FOR TESTING,
ADULTERATED, SUBSTITUTED and INVALID RESULT checkboxes; moved POSITIVE
checkbox to be under DILUTE
3. Added line for certifying scientist to record positive analytes and
concentrations, and added ``Analyte(s) in ng/mL'' instruction (aligned
under ``POSITIVE for:'')
Copy 2 (Medical Review Officer Copy)
Revised Step 6 (Donor Section)
1. Edited donor certification statement to state ``specimen bottle/
tubes''
Revised Step 7 (MRO Section--Primary Specimen)
1. Put Urine and Oral Fluid checkboxes above Step 6 for MRO to annotate
Bottom of Copies
Revised Copy 1
1. Edited label/seal at bottom of Copy 1 to allow for modification
(e.g., perforations, label with transparent seal on one side, and
separate label and seal)
Revised Copies 3-5
1. Removed Steps 6 and 7 (MRO sections)
2. Moved Public Burden Statement from the back to the front of the
copies
Additional Edits to Copy 5
1. Moved Privacy Act Statement (for federal employees) from the back to
the front of the copy
2. Removed Instructions for Completing the CCF from the back. SAMHSA
will post instructions for completing the Federal CCF for urine and
oral fluid on their website.
Based upon information from federal agencies and from DOT
concerning their regulated industries, the number of respondents has
increased from 5.4 million to 6.7 million, which increases the total
burden hours by 170,701.8.
Laboratories and IITFs seeking HHS certification under the NLCP
must complete and submit the NLCP application form. The NLCP
application form has not been revised compared to the previous form.
Prior to an inspection, an HHS-certified laboratory or IITF is
required to submit specific information regarding its procedures.
Collecting this information prior to an inspection allows the
inspectors to thoroughly review and understand the testing procedures
before arriving for the onsite inspection. The NLCP information
checklist has not been revised compared to the previous form.
The annual total burden estimates for the CCF, the NLCP
application, the NLCP information checklist, and the NLCP recordkeeping
requirements are shown in the following table.
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Burden per
Form/respondent Number of Responses per Total number response Annual burden
respondents respondent of responses (hours) (hours)
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Custody and Control Form: \1\
Donor....................... 6,726,610 1 6,726,610 0.08 538,128.8
Collector................... 6,726,610 1 6,726,610 0.07 378,000
Laboratory.................. 6,726,610 1 6,726,610 0.05 336,330
IITF........................ 1 0 0 0.05 0
Medical Review Officer...... 6,726,610 1 6,726,610 0.05 270,000
NLCP Application Form: \2\
Laboratory.................. 5 5 5 3 15
[[Page 7778]]
IITF........................ 0 0 0 3 0
Sections B and C--NLCP
Inspection Checklist:
Laboratory.................. 29 1 29 1 29
IITF........................ 0 0 0 1 0
Record Keeping:
Laboratory.................. 29 1 29 250 7,250
IITF........................ 0 0 0 250 0
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Total................... 6,726,673 .............. 26,906,503 .............. 1,529,753
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Send comments to Carlos Graham, SAMHSA Reports Clearance Officer,
Room 15-E-57-A, 5600 Fishers Lane, Rockville, MD 20857 OR email a copy
to [email protected]. Written comments should be received by
April 13, 2020.
Jennifer Wilson,
Budget Analyst.
[FR Doc. 2020-02671 Filed 2-10-20; 8:45 am]
BILLING CODE 4162-20-P